A Study of the Safety, Efficacy and Tolerability of Nexvax-2 in Patients With Celiac Disease (CeD)

Study Purpose

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers

No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Study Type

Interventional

Eligible Ages

18 Years - 70 Years

Gender

All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Adults 18 to 70 years of age (inclusive)
- History of medically diagnosed celiac disease (CeD) that included duodenal biopsy
- Maintenance of gluten free diet (GFD) for at least 12 consecutive months prior to
screening.

- Willingness to consume a moderate amount of gluten
- Able to read and understand English
- Worsening of GI symptoms in response to an oral gluten challenge
- HLA DQ 2.5 positive

Exclusion Criteria:

- Any medical condition or lab abnormality that in the opinion of the investigator may
interfere with study conduct or would impact the immune response (other than CeD),
confound interpretation of study results, or pose an increased risk to the subject.

- Use of immunomodulatory or immune-suppressing medical treatment during the 6 months
prior to screening
- Use of oral or parenteral immunomodulatory corticosteroids, within the 6 weeks prior
to screening.

Topical or inhaled corticosteroids are acceptable.

- Receipt of any investigational drug or participation in another clinical study within
6 months prior to screening.

- Females who are lactating or pregnant
- Receipt of any vaccine within 1 week prior to planned first day of the treatment
period.

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

A phase 2, randomized, double-blind, placebo-controlled clinical study of Nexvax2, in adults
subjects with confirmed CeD who have been following a gluten free diet for at least 12
consecutive months prior to screening. This study will evaluate efficacy of Nexvax2
administered subcutaneously. The study plan consists of 3 periods: a screening period of 6
weeks, an approximately 16 week treatment period, and a 4 week post-treatment observational
follow-up.

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